Cleared Special

EM44 SELF MONITORING BLOOD GLUCOSE SYSTEM, EM44 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM

K112272 · Eps Bio Technology Corp. · Chemistry
Sep 2011
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K112272 is an FDA 510(k) clearance for the EM44 SELF MONITORING BLOOD GLUCOSE SYSTEM, EM44 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM, a Glucose Dehydrogenase, Glucose (Class II — Special Controls, product code LFR), submitted by Eps Bio Technology Corp. (Hsinchu, TW). The FDA issued a Cleared decision on September 7, 2011, 30 days after receiving the submission on August 8, 2011. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K112272 FDA.gov
FDA Decision Cleared SESE
Date Received August 08, 2011
Decision Date September 07, 2011
Days to Decision 30 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code LFR — Glucose Dehydrogenase, Glucose
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1345

Similar Devices — LFR Glucose Dehydrogenase, Glucose

All 72
FreeStyle InsuLinx Blood Glucose Monotioring System
K152328 · Abott Laboratories · Sep 2015
ACCU-CHEK AVIVA EXPERT SYSTEM
K142089 · Roche Diagnostics Corporation · Dec 2014
EGV1.1 SELF MONITORING BLOOD GLUCOSE SYSTEM AND EGV1.1 PRO MONITORING BLOOD GLUCOSE SYSTEM
K133537 · Eps Bio Technology Corp. · Apr 2014
CERA-CHEK 1070 BLOOD GLUCOSE MONITORING SYSTEM
K131727 · Ceragem Medisys, Inc. · Feb 2014
ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEM
K131366 · Roche Diagnostics Operations, Inc. · Oct 2013
NOVA MAX MINI BLOOD GLUCOSE AND B-KETONE MONITOR
K122688 · Nova Biomedical Corporation · Apr 2013